Date: 2014-02-28
Type of information: Initiation of development program
phase: 2
Announcement: preparation of the trial
Company: Biotie Therapies (Finland)
Product: SYN120
Action
mechanism: SYN120 is a selective and orally bioavailable 5HT6 receptor antagonist, exclusively targeting regions in the brain associated with memory function. SYN120 has been shown to enhance cognition in various preclinical models.
Disease: Alzheimer's disease
Therapeutic area: CNS diseases - Neurodegenerative diseases
Country: USA
Trial
details: The trial of healthy volunteers is being conducted by Dr Dean Wong at the Johns Hopkins University School of Medicine in the United States to determine occupancy of the 5-HT6 receptor in the brain following different doses of SYN120. This will help to establish the appropriate dose for subsequent Phase 2 trials.
Latest
news: * On February 28, 2014, Biotie has announced that the company intends to develop internally SYN120. Biotie has been in advanced discussions for a partnership for further development and commercialization of SYN120, its oral, dual antagonist of the 5-HT6 and 5HT2a receptors. These two distinct properties could result in a unique therapeutic profile for SYN120 combining pro-cognitive and antipsychotic activities. SYN120 has completed single and multiple ascending dose Phase 1 clinical studies and a Phase 1 positron emission tomography imaging study to determine therapeutic dose for subsequent Phase 2 studies. The Company has now concluded that Biotie will be better served by progressing SYN120 internally to the next stage of development. Preparations for a Phase 2 study in Alzheimer's disease have started, with the study expected to begin recruitment by the end of 2014.
* On June 26, 2012, Biotie has announced that Roche has decided to not exercise its rights to SYN120. The Finnish company is retaining global development and commercialization rights to SYN120, following Roche's decision not to exercise its opt-in right due to strategic portfolio reasons. SYN120 has an extensive package of clinical and preclinical data and is ready to enter Phase 2. Biotie has also indicated that several companies have already expressed an interest in the compound.
* On March 1, 2012, Biotie has announced the completion of this Phase 1 clinical study using positron emission tomography (PET) imaging for its 5-HT6 receptor antagonist SYN120. The study was designed to establish the appropriate dose of SYN120 for Phase 2 trials in cognitive disorders, including Alzheimer's disease and schizophrenia. The PET study has evaluated occupancy of the 5-HT6 receptor in the brain in nine healthy volunteers who were treated with different doses of SYN120. The results demonstrate that target levels of receptor occupancy expected for efficacy can be achieved with SYN120 doses that are an order of magnitude lower than those that have previously been shown to be safe and well tolerated for up to two weeks in healthy older volunteers. Biotie is in the process of preparing a Phase 2 enabling package to be submitted to Roche for their evaluation.
